Picolax (sodium picosulfate) oral drops 0.75% 15 ml. vial

Description

Picolax composition
active substance: sodium picosulfate;
1 ml of the drug contains sodium picosulfate in terms of 100% anhydrous substance 7.5 mg (20 drops);
excipients: sorbitol (E 420); sodium benzoate (E 211); citric acid, monohydrate; sodium citrate; water for injections.

Dosage form
Oral drops.

Pharmacological properties
Sodium picosulfate, the active ingredient of Picolax, is a topical laxative of the triarylmethane group. Sodium picosulfate after bacterial cleavage in the colon stimulates its mucous membrane, accelerating peristalsis, promotes the accumulation of water and electrolytes in the lumen of the colon. The result is stimulation of bowel movements, a decrease in transit time and softening of the stool.

Indications
Constipation or cases requiring relief of bowel movements.
Like other laxatives, Picolax should not be used daily or for a long period without identifying the cause of the constipation.

Contraindications:

• Hypersensitivity to the active substance, other triarylmethanes or to any of the excipients of the drug;
• Dynamic or mechanical intestinal obstruction;
• Severe painful and / or febrile diseases of the abdominal organs (eg, appendicitis), which are potentially associated with nausea and vomiting;
• Acute inflammatory bowel disease;
• Severe dehydration;
• Rare hereditary intolerance to any of the excipients of the drug, for example, there is a possibility of an unknown fructose intolerance;
• The drug should be taken under medical supervision for conditions associated with imbalance in water and electrolyte balance (for example, in severe renal impairment).

Children
Picolax should not be administered to children under 4 years of age.

Application during pregnancy or lactation.
Pregnancy
Appropriate clinical studies in pregnant women have not been conducted. Animal studies have demonstrated the reproductive toxicity of the drug when used in daily doses of 10 mg / kg and above. For safety reasons, Picolax should not be used if possible during pregnancy.
Breastfeeding period
Clinical data show that neither the active metabolite of bis- (p-hydroxyphenyl) -pyridyl-2-methane (BHPM) nor its glucuronides pass into breast milk. Thus, Picolax can be used during breastfeeding.

Method of administration and dosage
The drug is dosed using the manufacturer’s dispenser.
Adults: 13-27 drops (corresponding to 5-10 mg of sodium picosulfate);
Children from 4 years old (only as prescribed by a doctor): 7-13 drops (which corresponds to 2.5-5 mg of sodium picosulfate).
It is recommended to start with the lowest dose. The dose can be adjusted to the maximum recommended dose for regular bowel movements. The maximum daily dose, which is 27 drops (for adults) or 13 drops (for children aged 4 and above), should not be exceeded.
The laxative must be taken at night. After using the drug, bowel movement occurs after 10-12 hours. The drug can be used with or without liquid.
The drug should not be used daily or for a long period without establishing the cause of constipation.

Overdose
Overdose can lead to loose stools (diarrhea), intestinal cramps, and clinically significant loss of fluid, potassium, and other electrolytes.
In case of acute overdose, the consequences can be minimized or eliminated by forced vomiting or gastric lavage a short time after taking the drug Picolax, oral drops. It may be necessary to replenish fluid and correct electrolyte balance. Antispasmodics can be used.
It has been reported about ischemia of the mucous membrane of the large intestine when using large doses of Picolax, significantly exceeding those usually recommended for constipation.
Laxatives, with prolonged overdose, can lead to chronic diarrhea and abdominal pain, hypokalemia, secondary hyperaldosteronism, and possibly kidney stones. With prolonged abuse of laxatives, renal tubular damage, metabolic alkalosis, and muscle weakening due to hypokalemia have been reported.

Side effects:

• On the part of the skin and subcutaneous fat: skin reactions (angioedema, drug toxicoderma, rash, itching);
• From the immune system: allergic reactions;
• From the nervous system: dizziness;
• From the gastrointestinal tract: diarrhea, abdominal discomfort, abdominal pain, abdominal cramps.

Prolonged and excessive use of the drug can lead to loss of fluid, potassium and other electrolytes. This, in turn, can lead to muscle weakness and impaired heart function, especially when used simultaneously with diuretics or corticosteroids.

Shelf life
3 years.
Do not use the drug after the expiry date indicated on the package.

Storage conditions
Store in its original packaging at a temperature not exceeding 25 ° C.
Keep out of the reach of children.